U.S. patent number 7,278,972 [Application Number 10/347,966] was granted by the patent office on 2007-10-09 for combined bone marrow aspiration and core biopsy device.
This patent grant is currently assigned to WorldWide Medical Technologies, LLC. Invention is credited to Gary A. Lamoureux, Richard A. Terwilliger.
United States Patent |
7,278,972 |
Lamoureux , et al. |
October 9, 2007 |
**Please see images for:
( Certificate of Correction ) ** |
Combined bone marrow aspiration and core biopsy device
Abstract
A combined bone marrow aspiration and core biopsy device. A
large bore cannula includes a coaxial stylet which seals both ends
of the cannula, allowing fluid to be aspirated through the space
between stylet and cannula. Then, a core sample is taken with the
cannula after the stylet is retracted.
Inventors: |
Lamoureux; Gary A. (Woodbury,
CT), Terwilliger; Richard A. (Southbury, CT) |
Assignee: |
WorldWide Medical Technologies,
LLC (Oxford, CT)
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Family
ID: |
26995497 |
Appl.
No.: |
10/347,966 |
Filed: |
January 21, 2003 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20030139688 A1 |
Jul 24, 2003 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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60350536 |
Jan 24, 2002 |
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Current U.S.
Class: |
600/567; 600/562;
600/563; 600/564; 600/565 |
Current CPC
Class: |
A61B
10/025 (20130101); A61B 10/0266 (20130101); A61B
10/0283 (20130101); A61B 2010/0225 (20130101) |
Current International
Class: |
A61B
10/00 (20060101) |
Field of
Search: |
;600/564,563,565,567,562 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Hindenburg; Max F.
Assistant Examiner: Hoekstra; Jeffrey
Attorney, Agent or Firm: McCormick, Paulding & Huber
LLP
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
This application claims the benefits of prior filed, co-pending
provisional patent application Ser. No. 60/350,536 filed Jan. 24,
2002.
Claims
The invention claimed is:
1. An improved combined bone marrow aspiration and core biopsy
device of the type having a cannula with proximal and distal ends
adapted to capture a core sample of bone marrow, the cannula having
a wall extending between its proximal and distal ends including a
cylindrical wall portion of a first internal diameter and having a
tapered wait portion on its distal end terminating in a distal
opening of a second smaller diameter than the first diameter, a
cannula handle attached to the cannula proximal end and defining a
conduit communicating with said cannula and having a proximal
opening, a stylet having a body with proximal and distal ends
slidably disposed within the cannula and defining an annular
passage between the inside of the cannula cylindrical wall portion
and the outside of the stylet body, and a stylet handle attached to
the proximal end of the stylet, wherein the improvement comprises:
a first fluid seal blocking fluid flow through said proximal
opening when the stylet is moved to an aspirating position. a
second fluid seal simultaneously blocking fluid flow through said
distal opening when the stylet is moved to said aspirating
position, at least one fluid aspirating port in the cannula wall on
the distal end thereof communicating with said annular passage
adjacent the distal end of the cannula, and at least one fluid
collection port communicating with the annular passage adjacent the
proximal end of the cannula, whereby fluid is withdrawn from
outside the cannula, through the aspirating ports through said
annular passage and collected through the collection port.
2. The improvement according to claim 1, wherein the first fluid
seal comprises a sealing member disposed to be engaged between the
cannula handle and the stylet handle, when the stylet is moved to
said aspirating position.
3. The improvement according to claim 1, wherein said second fluid
seal is made between the stylet distal end and the cannula tapered
wall portion.
4. The improvement according to claim 1, wherein said at least one
fluid aspirating port is an opening through the cannula tapered
wall portion.
5. The improvement according to claim 1, including a collection
conduit defined in the cannula handle and communicating with said
fluid collection port.
6. An improved combined bone marrow aspiration and core biopsy
device of the type having a cannula with proximal and distal ends
adapted to capture a core sample of bone marrow, the cannula having
a wall extending between its proximal and distal ends including a
cylindrical wall portion of a first internal diameter and having a
tapered wall portion on its distal end terminating in a distal
opening of a second smaller diameter than the first diameter, a
cannula handle attached to the cannula proximal end and defining a
conduit communicating with said cannula and having a proximal
opening, a stylet having a body with proximal and distal ends
slidably disposed within the cannula and defining an annular
passage between the inside of the cannula cylindrical wall portion
and the outside of the stylet body, and a stylet handle attached to
the proximal end of the stylet, wherein the improvement comprises:
a first fluid seal blocking fluid flow through said proximal
opening when the stylet is moved to an aspirating position
comprising a yieldable sealing member disposed to be engaged
between the cannula handle and the stylet handle, a second fluid
seal simultaneously blocking fluid flow through said distal opening
when the stylet is moved to said aspirating position, wherein the
distal end of the stylet body has a diameter between that of the
cannula first internal diameter arid that of the second smaller
diameter, said second fluid seal being made between the stylet
distal end and the cannula tapered wall portion so as to close said
distal opening, at least one fluid aspirating port in the cannula
wall on the distal end thereof communicating with said annular
passage adjacent the distal end of the cannula, and at least one
fluid collection port communicating with the annular passage
adjacent the proximal end of the cannula, whereby fluid is
withdrawn from outside the cannula, through the aspirating port,
through said annular passage and collected through the collection
port.
Description
BACKGROUND OF THE INVENTION
A bone marrow biopsy is a test performed by a physician to evaluate
bone marrow function. Bone marrow produces red blood cells, white
blood cells, and platelets. This test allows the doctor to study
these cells in the various stages of development to better plan
treatment of bone disease.
The physician may recommend blood tests or special imaging tests
such as a bone scan, a CT (or CAT) scan, an MRI, or an angiogram to
ascertain the need for intervention into the bone marrow space. A
biopsy may be prescribed to remove blood and fluid aspirates from
the marrow space as well as a core sample of the bone marrow to
determine whether cancer or other disease is present.
In the procedure, two types of samples are required for a full
diagnosis. Fluid or aspirate must be drawn from the marrow cavity
for cytological study and a core sample of marrow material must be
obtained for histological study.
In the conventional prior art procedure, the physician penetrates
the hard bone of the patient with a series of different needles
from a bone marrow biopsy set. The first needle used is a small
bore needle designed to aspirate fluid for cytological study. The
small bore needle is twisted down through the cortex of the bone
into the marrow space. Once the marrow cavity is accessed, the
stylet of the small bore needle is removed and a syringe is
attached to the opening where the stylet resides. A fluid sample is
withdrawn from the marrow space using the syringe attached to the
needle. The bore of the needle used to aspirate fluid must be small
so that the small amount of fluid that is available can be drawn up
the needle into the syringe. If the needle is too large in internal
diameter, there is not enough fluid available to fill the internal
volume of the bore and still have enough aspirate fluid available
to reach up the full length of the needle and to fill the
syringe.
After this aspirated fluid is removed, a second hole must be
created in the cortex to obtain a solid marrow sample or core. This
second hole is required because the act of aspirating fluid from
the marrow dries out the marrow in that area making it unsuitable
to obtain a satisfactory marrow core sample.
A large bore needle is used to create this second hole. This larger
bore needle is designed with a cylindrical body of a first
diameter, tapering to a distal end of a second diameter. The needle
is tapered in the last 2 to 3 centimeters of the distal end to a
smaller sharpened opening with a cutting edge. This reduced second
diameter of the large bore needle assists in capturing and holding
the core sample as it is removed from the patient.
Once the hard bone is penetrated, by the large bore needle, the
stylet of the needle is removed and the hollow cannula of this
second needle is driven into the marrow space to obtain a solid
core of marrow. The large bore needle is removed from the patient
and the marrow sample is removed. This second needle has a much
larger internal bore than the needle used to aspirate, so that the
marrow can easily be cored and removed from the marrow cavity.
A bone marrow surgical needle is disclosed in U.S. Pat. No.
5,012,818 to Joishy. Joishy discloses a biopsy needle with a
tubular outer sleeve in which two separate conduits are contained.
The first conduit is used to obtain the solid bone biopsy sample.
The second conduit is used to obtain the fluid bone marrow biopsy
sample. Each conduit contains two removable stylets. The handle of
the Joishy needle can be opened to remove the stylets from each
conduit and attach a syringe to aspirate the bone marrow biopsy
sample. The needle is tapered at the cutting end to assist in
breaking off and retaining the bone biopsy sample. During use, the
needle is pushed into the bone and the handle of the biopsy needle
is opened. The first stylet is then removed thereby leaving an
opening in the first conduit to receive a solid bone biopsy sample
and the handle is again closed. The needle is then pushed further
into the bone and the hard bone biopsy sample enters the first
conduit. The handle is again opened and the second stylet is
removed from the second conduit. A syringe is attached to second
conduit at the handle and the bone marrow biopsy sample is
aspirated through the second conduit and into the syringe. The
needle is then manipulated to assist in breaking off the bone
biopsy sample and then removed from the subject.
The Joishy needle requires a sleeve with two conduits and two
removable stylets within the conduits. The biopsy procedure
requires multiple steps to perform and therefore can be
time-consuming. Also, the manufacture of such a complex needle can
be difficult and costly.
U.S. Pat. No. 6,007,496 issued Dec. 28, 1999 to Brannon describes a
device for harvesting bone, including a hollow cylindrical rod
having a sharpened distal end, a proximal end with a handle
thereon, and a chamber therein extending axially between the
proximal and distal ends. A plunger rod is inserted into the
proximal end of the cylindrical rod, the plunger rod being slidable
axially within the chamber. A sealing support is provided on the
proximal end of the hollow cylindrical rod for engaging the plunger
rod to establish a slidable hermetic seal therebetween and prevent
retrograde flow of air into the chamber from the proximal end of
the cylindrical rod. The sleeve also includes a side opening in the
cylindrical rod communicating with the chamber, which is
connectable to a source of vacuum for evacuating fluid from the
chamber into a fluid reservoir connectable to the side opening for
collecting fluid therein. The plunger rod must be constantly
advanced to compensate for pressure drop due to collapse of the
collected sample at the distal end of the cannula.
U.S. Pat. No. 6,022,324 issued Feb. 8, 2000 to Skinner shows a
biopsy instrument, which can be used to take a bone biopsy sample
or a soft tissue biopsy sample. The biopsy instrument includes a
biopsy needle and a biopsy gun. In operation, a triggering
mechanism actuates a firing mechanism causing the cradle together
with the needle and the attached syringe to fire forward with a
sufficient force such that the needle penetrates the target tissue
organ causing a first tissue sample to be cored in the needle. The
disposable syringe can then be used to obtain a second tissue
sample up through the biopsy needle using a vacuum created in the
disposable syringe when the plunger is maintained in a rearward
position while the syringe fires forward. In a bone biopsy
procedure, the first tissue sample is a bone sample and the second
tissue sample is a liquid bone marrow sample. The entire bore of
the core sample needle is used to aspirate the fluid sample, which
may not be sufficient to fill the needle bore for the full length
of the needle.
Skinner employs a retainer projecting into the cannula bore from
its larger diameter to retain the cored hard biopsy sample. The
sample has a smaller cross-sectional area equal to that of the
tapered distal end of the cannula.
It would be desirable to have an improved needle assembly requiring
only one entry site into the bone that allows aspirated fluid to be
drawn in a sufficient amount for cytological study from the areas
adjacent the sides of the needle without disturbing the marrow
directly in front of and below the needle tip and that allows the
same needle to core the undisturbed marrow in a sufficient amount
for histological study from the same needle assembly.
Accordingly, one object of the present invention is to provide an
improved needle assembly that requires only one entry site into the
bone to obtain aspirate fluid and bone marrow core sample.
Another object of the invention is to provide an improved needle
assembly that allows aspirated fluid to be drawn from the areas
adjacent to the sides of the needle and allows the same needle to
core the undisturbed marrow directly in front of and below the
needle tip.
SUMMARY OF THE INVENTION
Briefly stated the invention is an improvement in a combined bone
marrow aspiration and core biopsy device of the type having a
cannula with proximal and distal ends, the cannula having a wall
including a cylindrical wall portion of a first internal diameter
extending between its proximal and distal ends, and having a
tapered wall portion on its distal end terminating in a distal
opening of a second smaller diameter than the first diameter, a
cannula handle attached to the cannula proximal end and defining a
conduit having a proximal opening, a stylet having a body with
proximal and distal ends slidably disposed within the cannula and
defining an annular passage between the cannula wall and the stylet
body, and a stylet handle attached to the proximal end of the
stylet. The improvement comprises a first fluid seal blocking fluid
flow from the proximal opening when the stylet is moved to an
aspirating position, a second fluid seal simultaneously blocking
fluid flow from the distal opening when the stylet is moved to the
aspirating position, at least one fluid aspirating port in the
cannula wall on the distal end, and at least one fluid collection
port in the conduit on the proximal end, whereby fluid may be
withdrawn from the aspirating port through the annular space and
collected through the collection conduit.
In its preferred embodiment the first fluid seal is a sealing
member disposed to be engaged to form a seal between the cannula
handle and the stylet handle. The distal end of the stylet body has
a diameter between that of the cannula first internal diameter and
that of the second smaller diameter, so as to engage the cannula
tapered wall portion to close the distal opening when the stylet is
moved to the aspirating position. The length of the stylet body and
length of the cannula are such that the two fluid seals are made at
the same time.
DRAWINGS
The invention will be better understood by reference to the
following description, taken in connection with the accompanying
drawings, in which:
FIG. 1 is a front elevational view, partly in cross-section, shown
with stylet in a withdrawn position in the cannula, and
FIG. 2 is a side elevational view, partly in cross-section, showing
the stylet inserted into an aspirating position.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring now to FIG. 1 of the drawing, the improved combination
bone marrow aspiration and core biopsy device is shown generally at
10 to comprise a cannula 12 with a proximal end 14 and a distal end
16. The proximal end 14 is flared at 18 and embedded in a cannula
handle 20, which is preferably of plastic material. The handle
includes handle extensions 21 to enable manual manipulation to
force the cannula tip through the bone cortex. The open proximal
end of the cannula communicates with a conduit 23 that terminates
in a proximal opening 24 facing the stylet handle 20.
Cannula 12 is constructed as a large bore hollow metal needle of a
type well known in the art for collecting a biopsy core sample.
Cannula 12 includes a cylindrical wall portion 26 of a first
internal diameter connecting with a tapered wall portion 28. The
tapered wall portion 28 terminates in a distal opening 30, which
has a second smaller diameter.
The internal diameter of the cannula lies in the range between 0.65
and 0.165 inches, and is preferably on the order of 0.121 inches.
The second smaller diameter of the distal opening lies in the range
between 0.045 and 0.138 inches, and is preferably on the order of
0.096 inches. The length of the cannula cylindrical portion is
about 3.0 inches and the length of the tapered portion is about 1.0
inches. The dimensions are suitable for capturing a core sample of
marrow material in a manner welt known in the art.
In order to aspirate fluid from the areas adjacent to the sides of
the cannula and to allow the same needle to core the undisturbed
marrow directly in front of and below the needle tip, one or more
aspirating ports are provided in the cannula wall. These are shown
as a port 32 in the tapered portion and a port 34 in the
cylindrical portion. Additional aspirating ports (not shown) may be
added.
Slidably disposed within the cannula 12 is a stylet (or trocar) 36
having a proximal end 38 and a distal end 40. Extending between the
proximal and distal ends is a cylindrical body 42. The space
between the wall of cannula cylindrical portion 26 and the stylet
body 42 comprises an annular passage 44. The distal end 40 of the
stylet has a diameter in between that of the first and second
diameters of the cannula. In the embodiment shown, the diameter of
the stylet distal end 40 and the diameter of the stylet body 42 are
the same, but they need not be so. The diameter of the stylet body
may either be larger or smaller than that of the stylet distal end
in order to adjust the volume of the annular passage 44.
Attached to the proximal end of stylet 36 is a stylet handle 48. It
is provided with gripping surfaces 50 in order to manually
manipulate it, while holding the extensions 21 of the cannula
handle 20, to slide the stylet in the cannula between a withdrawn
position shown in FIG. 1 to an aspirating position shown in FIG.
2.
In accordance with one aspect of the present invention, a sealing
member 52 is disposed at the proximal end 38 of the stylet. Sealing
member 52 is shown as a tapered member designed and arranged to
enter the proximal opening 24 to provide a first fluid seal.
Sealing member 52 may either be a separate elastomeric piece
threaded over the stylet body or may be an integral part of the
stylet handle plastic molding. Although it is shown as a tapered
member designed to enter the opening 24, it may also comprise a
yieldable member covering and blocking off opening 24 as the stylet
is advanced.
In accordance with the present invention, the length of the stylet
body is such that when the first fluid seal is made, the stylet
distal end also simultaneously engages the tapered wall portion 28
of the cannula to form a second fluid seal.
Reference to FIG. 2 of the drawing shows further details of the
improved combination bone marrow aspiration and core biopsy device
10. The device has been rotated about its axis to reveal that
collection conduit 54 is provided in the cannula handle 20 which
communicated with annular passage 44 through a collection port 56.
A syringe 58 may be inserted into the collection conduit 54 to
collect aspirated fluid, as shown.
Also in FIG. 2, the stylet 36 is shown advanced to an aspirating
position. In this position the first fluid seal is formed by
sealing member 52 and the second fluid seal is formed by the distal
end of 40 simultaneously engaging the smaller diameter of the
tapered wall portion. In this position the fluid may be aspirated
from the undisturbed bone marrow area behind the cannula tip
through the annular passage 44, collection conduit 56 into the
syringe. Because the volume in the annular space 44 is very small,
a very small sample may be withdrawn without the problem of filling
the entire length of a large bore needle.
Operation
With the inventive device, multiple needles are eliminated as well
as multiple points of entry into the bone. The large bore inventive
device, with the stylet in place, is twisted through the cortex of
the bone. Keeping the stylet in place, the large bore needle is
first advanced into the marrow 2 to 3 centimeters to assure the
aspirating ports 32, 34 of the cannula are down into the marrow
space. The syringe 38 is attached to a port of the collection
conduit in the side of the large bore cannula handle that accesses
the annular passage between the cannula and the stylet of the
assembly. Suction is drawn with the syringe, because the stylet is
sealed at the proximal end of the handle with a seal and the stylet
distal tip is blocking the tapered distal end of the open
cannula.
Fluid is drawn through the aspirating ports of the cannula and
aspirated up into the syringe. The stylet body 42 is of sufficient
size as to reduce the overall internal volume of the large bore
cannula thus allowing what fluid is available in the marrow space
to be able to fill this reduced annular passage within the needle
and still have sufficient fluid left to fill the syringe.
Once an aspirated sample is withdrawn into the syringe, the syringe
is removed and the stylet of the needle is pulled out of the
cannula bore. The large bore cannula is driven down into the marrow
space to obtain a core sample of marrow material and the needle
assembly is then withdrawn from the patient.
The improvements claimed for this inventive combined aspiration and
marrow-coring needle are: 1) A needle assembly that requires only
one entry site into the bone to obtain aspirate fluid and bone
marrow core sample; 2) A needle assembly that allows aspirated
fluid to be drawn from the areas adjacent to the sides of the
needle and allows the same needle to core the undisturbed marrow
directly in front of and below the needle tip; 3) A needle assembly
that reduces the overall time a bone marrow biopsy procedure is
preformed in with less trauma to the patient; 4) A needle assembly
so constructed as to allow the stylet to remain in place during the
aspiration of fluid thus minimizing the internal volume within the
needle where the fluid flows allowing a large bore needle to be
used for the withdrawal of fluid into an attached syringe; 5) A
needle assembly that provides a large bore opening of sufficient
size as to allow the collection of solid marrow material from the
bone; 6) A means to attach a syringe to the needle assembly handle
with the stylet of the large bore needle still in place; 7) A
needle assembly where the stylet remains in place to close off the
open end of the large bore needle during the withdrawal of fluid
aspirate; 8) A needle assembly that provides for a side hole or
multiple side holes piercing the outer body of the large bore
needle near the distal tip to allow fluid to pass into the internal
diameter of the large bore needle while the open distal end of the
large bore needle is closed off by the stylet being in place; 9) A
needle assembly that includes a fluid tight seal on the stylet rod
at the proximal end creating a sealed fluid pathway from the distal
tip of the cannula into the attached syringe.
While there has been described what is considered to be the
preferred embodiment of the invention, other modifications will
occur to those skilled in the art, and it is desired to secure in
the present application all such modifications as fall within the
true spirit and scope of the invention.
* * * * *